Shots:

• The P-I/III (ROSALIA) trial evaluating biosimilar denosumab in 527 postmenopausal women with osteoporosis for ~78wks. The trial met its 1EPs i.e., biosimilar denosumab had similar PD, PK, safety, efficacy & immunogenicity over reference medicine in the respective indications
• In June 2022, the high-concentration formulation 100mg/mL (HCF) of Sandoz's biosimilar adalimumab application has been accepted for review by the EMA & US FDA
• Denosumab is a human mAb that binds to RANKL protein & is indicated for osteoporosis in postmenopausal women, in men who are at high risk of fractures, treatment-induced bone loss, prevention of skeletal-related complications in cancer & giant cell tumor of the bone

Ref: Novartis | Image: Sandoz